Medical heated face mask

ABSTRACT

A heated medical face mask is provided, including, a first outer layer having an outer surface and an inner surface; a second, inner layer having an outer surface and in inner surface; the first and second layers being fastened together around corresponding peripheral side and bottom edges but being open along an upper edge or side edge to form a pocket; and a heating element being releasably located in the pocket.

RELATED APPLICATIONS

This application is related to and claims priority under 35 US 119 from U.S. Provisional Ser. No. 63/017,237 filed Apr. 29, 2020, and U.S. Provisional Ser. No. 63/105,700 filed Oct. 26, 2020 the contents of which are incorporated by reference herein.

BACKGROUND

The present invention relates to a medical face mask used to prevent and/or treat viral respiratory infections, including but not limited to infection by SARS-Cov-2 (COVID-19) virus.

While the COVID-19 virus is a relatively recent occurrence, preliminary research indicates that the virus is susceptible to elevated temperatures in the range of 100° F. and above. There is a ten-fold drop in SARS-CoV-1 viability in going from 33 degrees C. (91.4 degrees F.) to 38 degrees C. (100.4 degrees F.). The SARS-CoV-1 virus is killed completely in 30 minutes at 75 degrees C. (167 degrees F.). The author believes that SARS-Cov-2 (COVID-19) will respond the same. Basic Biology of COVID-19 Virus (SARS-CoV-2): How Sensitive is the Virus to UV? How Long Does It Survive on Cardboard or Plastic? Michael Z. Lin, MD, PhD, Stanford Medicine; March 2020, Continuing Medical Education, Department of Neurobiology at the Stanford University School of Medicine. VUMEDI

https://www.vumedi.com/video/basic-biology-of-covid-19-virus-sars-cov-2/

Staying warm when one has a sniffle seems logical, and in 2016, US scientists discovered that a warmer body temperature actually helps fight the common cold virus more quickly. Coincidentally, four types of Coronavirus are responsible for the common cold. It was found that at core body temperature, infected cells die more rapidly, preventing viral replication. The Jul. 13, 2016 study was published by the Proceedings of the National Academy of Sciences and revealed how body temperature affects the immune system's response to the common cold virus.

Additional research on the effect of elevated temperatures on COVID-19 virus viability was documented by Akiko Iwasaki, Professor of Immunobiology Yale University, British Journal of Pharmacology, Jul. 13, 2016.; Duan, et al; Stability of SARS coronavirus in human specimens and environment and its sensitivity to heating and UV irradiation; Biomed Environ Sci.; 16 (3); 246-55; September 2003; and Chan et al; The Effects of Temperature and Relative Humidity on the Viability of the SARS Coronavirus; Adv. Virol; 2011:734690. Doi: 10.1155/2011/734690. Oct. 1, 2011.

Researchers at Yale University found that the common cold virus replicated more readily when the temperature in the nose of mice dipped below the core body temperature of 37 degrees C. Second, it was found that an enzyme that attacks and degrades viral genes, RNA seL, is enhanced at the higher temperatures. Foxman, et al., Temperature-dependent innate defense against the common cold virus limits viral replication at warm temperature in mouse airway cells; Proc. Nat. Acad. Sci. USA 2015 Jan. 20. PMID: 25561542d. More recently, Oct. 20, 2020 Exposure of SARS-CoV-2 to high temperatures can kill the coronavirus. Can High Temperatures Kill the New Coronavirus? Taken from healthline com and Medically Reviewed by Joseph Vinetz, MD, and written by Jill Seladi-Schulman, Ph.D. (See FIG. 12)

Accordingly, there is a need for a way of increasing internal body and/or respiratory tract temperature to prevent or reduce virus-caused symptoms, particularly those of COVID-19. In addition, the goal would be to decrease the titer of viable virus entering the airway and as a result, stimulating an immune response to develop antibodies, IGA, IGM, and IGG as well as T-Cell Immunity. Essentially, the mask may function as a wearable vaccine.

Heated medical face masks are known in the art, and are disclosed in U.S. Pat. Nos. 4,601,287; 4,793,343; 5,551,154; and 8,960,190 among others. However, conventional heated medical face masks have built-in or integral heating systems. Such masks are difficult, if not impossible to clean, and once soiled must be disposed of, adding to the already large volume of medical waste.

In view of the rapid spread of the COVID-19 virus, many jurisdictions have passed regulations requiring that medical face masks be worn by the general populace while circulating in public in an effort to reduce cross-contamination and infections.

Thus, there is a need for an improved medical face mask, usable by the general public, which addresses the above-listed needs.

SUMMARY

The above-listed needs are met or exceeded by the present medical face mask intended for the general population. A heating element is releasably attached to or incorporated into the mask. Once the heating element is activated, by inhaling the warmed dry air generated by the heating element contained within the present face mask, it is envisioned that a decrease in the amount of inhaled viable virus can be achieved. It is envisioned that any virus particles that become trapped in the present mask will be deactivated due to exposure to high temperatures within the mask. As a result, it is contemplated that, after wearing the present mask for designated periods of time, or simply when out and about, the wearer, if exposed to a viral load, will have a greater chance of being asymptomatic, or will have a mild case, and will potentially still develop immunity.

It is also contemplated that in colder climates, the user may use the present heated face mask for breathing warmer air as a means of staying warm outdoors. A heating pack, either disposable or battery powered and reusable, is secured within the mask, preferably within an internal pocket or fabric barrier to prevent the heating pack from contacting the wearer's face. Thus, the heating element is maintained in a spaced distance from the wearer's nose and mouth. The spacing particularly pertains to the heating element being powered by a higher voltage Li-ion battery (11.1V) with three levels of output. As the heated temperature can reach 200 degrees F., obviously the spacing from the wearer's face is advisable. In this scenario, the wearer is actually breathing in air that has a temperature averaged between the wearer's exhale and the temperature of the heating pad. Temperatures in the 150-160 degrees F. range have been demonstrated to result in a 5-6-fold logarithmic drop-off in viable virus (a 7-fold logarithmic reduction is equal to sterilization). For the purpose of comfort in the cold, the heating element (pack or pad or hand warmer) can be close to the skin. A lower voltage Li-ion battery 7.4 volts 2600 mAh or 3400 mAh with four levels of output can be used for this purpose. The same heating pad can be used for the higher and more comfortable lower temperatures by simply utilizing a more or less powerful Li-ion battery. Of course, the mask design for the higher temperature heating needs to avoid contact between the heating element and the wearer's skin. For this purpose, the duckbill face mask is indicated. An even lower voltage Li-ion Battery of 7.4V, and 2600 mAh or 3400 mAh may also be effective by varying the size of the battery powered heating elements as well as the “Bus Bar” distances using the conductive media FabRoc™.

Another feature of the present medical face mask is that the heating element is preferably contained in a pocket defined in the mask, so that the heating element is prevented from moving towards the wearer's skin and also is replaceable when it expires, is removable and washable or able to be disinfected for reuse, or alternatively, to allow for laundering or disinfecting of the mask for re-use. In addition, the present mask is thus optionally usable without the heating element. For the higher temperature heating and heating element, the mask utilized is the duckbill face mask. In this mask, the heating pad is inside the mask and prevented from moving toward the wearer's facial skin by built-in stops, or preferably with an internal pocket or fabric barrier for preventing the heating pack or element from contacting the wearer's face.

More specifically, in a preferred embodiment, the present mask is composed of at least two layers of textile; either woven or non-woven, having one of the layers composing the inner layer unattached to the other layers at the top edge of the mask, and as a result, forming a pouch or pocket. Other textiles are also contemplated and included to compose the outer layer of the heated face mask such as the heat reflective material (Temptrol® material), and Gore-Tex® material. These last two textiles preferably constitute a whole outer layer of the mask, or are optionally sewn in or otherwise attached as a patch occupying a generally central portion of the area of the mask. In one embodiment, 80% of a preferably central region of the mask is used for the pouch or pocket. Another option of the present medical face mask includes a supplemental layer of textile material provided for wrapping around the heating element.

The present heated medical face mask is preferably washable or reusable, however disposable materials are also contemplated, and a modification of the typical disposable mask is envisioned to hold the heating element in a pouch composed of a separation of the inner layer of non-woven material from the outside layers along the top edge of the mask. If a battery-powered reusable heating element is to be used, another opening is needed on the wearer's left side for the power cord. For the masks in which the heating element is to reach higher temperatures, the cable simply is positioned along the bottom of the inner surface of the mask and simply exists the mask along the bottom edge. The disposable heating element is removed prior to laundering, or upon expiration of the heating element at the end of its operational life. In one embodiment, an exterior periphery of the present mask is dimensioned so that the heating element occupies approximately 80% of the surface area of an exterior layer of the mask. It is contemplated, as an option, that the size of the present medical face mask is dimensioned to be 10% or more larger than conventional masks in order to accommodate the heating element or cooling element and still have mask material to breathe through, while still offering protection to the surrounding community. Smaller percentages occupied by the heating element, as in approximately 25%-60%, are envisioned and preferred to allow for the passage of air through the mask. In addition, a battery powered heating pad with one or two ½″ diameter openings in the heating pad is also envisioned. If a heating element is approximately 40% of the mask surface area, this would obviate any need to have the mask manufactured 10% larger. The cooling elements are typically larger and may necessitate the increase in size of the mask. In some cases, smaller cooling elements are provided, leaving sufficient free space for air to pass through the mask for wearer respiration.

The mask can either be held in place upon the wearers face by loops of fabric to be placed around the ears, by ties attached to the top and bottom edge corners that are attachable behind the head and neck. Elastic bands that are attached at the top and bottom edge corners or secured to the side edges of the mask as seen in N95 or KN95 respirators i.e. to each end to respective parts of the fabric are also contemplated that are positioned around the wearer's head and neck.

An optional bendable metal or plastic piece sewn or otherwise secured into the middle of the top edge helps the mask conform to the bridge of the wearer's nose and act as a support for the mask. Such nosepiece stiffeners are known in the art. The addition of a plastic eye shield to the top edge is also contemplated.

In one embodiment, the heating element is placed inside the pouch formed between the inner layer of textile and the layer just beneath this layer. In the one embodiment, the heating element is chemical in nature, such as an air-activated warmer, which generates heat by the exothermic reaction of iron and air. Optionally, a conductive metal framework is provided within the pocket. Alternately, the heating element is contemplated as being battery-powered, and other ways to heat the inhaled air are envisioned. Temperatures generated by the heating element will need to be sufficiently high (200 degrees F.), for warming the air being breathed in by the wearer, as in the mask functioning as a wearable vaccine or in the 120-130 degrees F. range as in the mask functioning for comfort only. Conventional air-activated warmers generate temperatures in the range of 120-150° F. for a duration of up to 12 hours or longer. Battery-powered heating pads can be engineered to produce heat of more consistent duration. It is envisioned that other heating modalities, besides the ones mentioned be included.

The present face mask (more specifically pertaining to the higher temperature heating), was designed with the intention of protecting not only those individuals in close proximity to the wearer from the COVID-19 virus, (as conventional face masks do currently), but will additionally offer a degree of protection to the wearer as well. In protecting surrounding individuals, this mask will function as any other mask, although the degree of air passing through from the wearer to the environment may be more limited, but not too limited, and is a good quality. From an inhalation standpoint, the goal is to have air pass fairly easily through the mask, but in addition may also come through around the edges or through the mask where the heating element is not obstructing. Use of the small air-activated warmers as the heating modality will allow for more air to pass through the mask on inhalation, and will offer the same degree of protection to the surrounding public as any other mask. Air coming through the sides of the mask, or through the area of the mask free of the warming unit, is still warmed by passing over the surface of the heated inner layer. Air can also pass through an air-activated warmer as the material within the warmer is usually not homogeneously distributed.

This by no means excludes the use of the heated face mask by wearers trying to protect themselves from other pathogens including the common cold. Also, it is contemplated that the present medical face mask is wearable without the heating element. The heated face mask may also be of use to immunocompromised patients who would like to venture out, and by no means is its use limited to treatment of, or protection against COVID-19. The present medical face mask is also contemplated as being effective against the general influenza.

An important feature of the present medical face mask is the ability to generate heat to the extent that the wearer thus inhales heated air, which raises the internal temperature of the wearer's respiratory passages. As such, the present face mask performs the conventional function of preventing aerosols generated by the wearer in sneezing, coughing, talking and the like from escaping into the environment. In addition, the present mask depending upon the power source, offers a degree of protection to the wearer in that the air intake will be heated, resulting in a decrease in the number of viable inhaled viral particles (currently SARS-Cov-2 (COVID-19). By increasing the temperature of the wearer's respiratory passages, the wearer is contemplated as being protected from suffering from a severe case of viral infection, and instead, either becomes asymptomatic or has only a mild case. As a result of this, a degree of immunity may still be conferred by the generation of IGA, IGM and IGG antibodies, as well as cellular and mucosal immunity. In addition, the present heated face mask is contemplated for use in protecting the wearer from other infectious pathology such as the common cold and influenza, amongst other infectious agents spread through the air in the form of droplets or aerosol.

In one embodiment, the present heating element is releasably retained in an interior of the face mask by horizontally placed and vertically separated, generally parallel ribs of cloth, cord or the like that retain the element in place via friction and obstruction. In addition, the heating element is optionally provided with at least one throughbore for enhancing flow of ambient air through the element. For a more secure placement, the heating pad is placed behind a fabric barrier, and is thus unable to migrate towards the wearer's facial skin.

In another embodiment, the heating pack is replaced with a cooling pack, for use in warmer outdoor temperatures for keeping the wearer more comfortable while outdoors, and may offer a “prevent fogging” to one's eyeglasses or face shield.

More specifically, a heated medical face mask is provided, including, a first outer layer having an outer surface and an inner surface; a second, inner layer having an outer surface and in inner surface; the first and second layers being fastened together around corresponding peripheral side and bottom edges but being open along an upper edge or side edge to form a pocket; and a heating element being releasably located in the pocket.

In an embodiment, at least one fastening loop is secured to each peripheral side edge. In an embodiment, elastic straps, or fabric ties, having a pair of free ends are provided, each end being secured to a corresponding side edge of the joined first and second layers. In an embodiment, the heating element is one of air activated warmer, or a rechargeable battery powered heating element. In an embodiment, the heating element has an area dimensioned to be approximately at most 80% but preferably, a significantly lower % (as in approximately 25-60%) of the total mask surface area. of the joined first and second layers.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front view of the present medical face mask being worn;

FIG. 2 is a rear view of the present medical face mask equipped with a heating element;

FIG. 3 is a rear view of the present medical face mask of FIG. 2 shown cut-away to reveal the heating element;

FIG. 4 is a schematic view of another embodiment of the present medical face mask equipped with a modified heating element;

FIG. 5 is a rear of the duckbill face mask used for higher temperature heating and demonstrating the heating element held in place by horizontally positioned and vertically spaced ¼″ yarn or cord fastened to the inside of the mask with fabric glue. This prevents the high temperature heating element from moving toward the wearer's face and skin.

FIG. 6 is a rear view of the disposable medical face mask of FIG. 6 (on the left) equipped with a re-usable cooling pack; and a fabric re-usable mask containing a re-usable cooling pack on the right. The non-disposable cooling pack is in the center, below the two masks.

FIG. 7 is a rear view of another embodiment of the present medical face mask provided with a disposable heating element; (an air-activated warmer, or normal size hand warmer);

FIG. 8 is a front perspective view of another alternate embodiment of the present medical face mask, the duckbill face mask equipped with a battery powered heating element held in place by the parallel and vertically spaced, glued-on ¼″ yarn cords; and

FIG. 9 is a rear perspective of a fabric mask with a supplemental layer sewn to the rear surface to accommodate a heating or cooling element

DETAILED DESCRIPTION

Referring now to FIGS. 1-3, the present heated medical face mask is generally designated 10 having a first, outer layer 12 with an outer surface 14 and an inner surface 16. A second, inner layer 18 has an outer surface 20 and in inner surface 22. It is contemplated that the outer and inner layers 12, 18 are made of any suitable textile, woven or non-woven, including but not limited to cotton, nylon, Temptrol® material, Gore-Tex® material, or other textiles known to those skilled in the art for manufacturing medical face masks. The typical surgical face masks are made with non-woven fabric, created using a melt blowing process, which has better bacteria filtration and air permeability while remaining less slippery than woven cloth. The material most commonly used to make them is polypropylene, either 20 or 25 grams per square meter (gsm) in density. From further research, surgical masks are made up of several layers of non-woven plastic and can effectively filter very small particles, such as droplets of SARS-CoV-2. The masks typically have an external waterproof layer 12 and an internal absorbent layer shown in the figures as 18.

In the preferred embodiment, the first and second layers 12, 18 are fastened together around corresponding peripheral side edge 24 and bottom edges 26 but being open along an upper edge 28 to form a pocket 30. An opening for the heating or cooling element may be on the side edge of the mask instead of the top edge. A temperature control element 32, preferably a heating element is dimensioned to be releasably located in the pocket 30. As is known in the art, the heating element 32 is contemplated as being one of air-activated, or battery powered and/or rechargeable (the battery being rechargeable). Also the heating element 32 is preferably washable and able to be disinfected. As described below, cooling elements are also contemplated as the temperature control element 32.

At least one fastening loop 34 is secured to each peripheral side edge 24. In an alternative to the loops 34, at least one elastic strap 36 is provided having a pair of free ends, each end being secured to a corresponding side edge of the joined first and second layers 12, 18. An alternative to the loop 34, or elastic strap 36, is fabric or textile ties attached to or adjacent to the four corners of the face mask to tie over the head and behind the neck as in the commonly used surgical mask.

In the preferred embodiment, the heating element 32 has an area dimensioned to be approximately 80% at most, and more preferably lower, as in 25%-60% of an area of the joined first and second layers 12, 18 which each share the same area. As an option the pocket 30 is defined by a supplemental layer 38 optionally an extension of the second layer 18, of material dimensioned for at least partially wrapping around the heating element 32.

Referring now to FIGS. 4 and 5, another embodiment of the present heated medical face mask is generally designated 40. Components shared with the face mask 10 are designated with identical reference numbers. One feature of the face mask 40 is that the inner layer 18 is provided with at least one and preferably a pair of vertically spaced, generally parallel retaining ribs 42 secured as by stitching, adhesives or the like. The ribs 42, preferably made of cordage or dense, rolled cloth, are spaced to retain the temperature control element 32 in place via friction, or simply obstruction.

The ribs 42 are configured for holding the temperature control element 32 in place by engaging a respective upper and lower element edge 44, 46 while the wearer walks or performs other non-strenuous activities. In the depicted embodiment, the ribs 42 secure the heating element 32 so that it is retained against the inner layer 18, and as such is somewhat distanced from the wearer's nose and mouth. As a result of this, higher temperature can be utilized.

As an alternate embodiment of the mask depicted in FIG. 5, the ribs 42 are replaced by a sheet of fabric 43 secured, as by stitching or the like to the interior of the mask. On one side edge, an opening 45 is provided for insertion of a rolled or folded heating element and optional cord. Once in the space defined by the fabric 43, the heating element is positioned to be relatively flat and to expand into the space. The fabric 43 functions to separate the heating element from the wearer's face.

Another feature of the face mask 40 is that the heating element 32 is provided with at least one optional throughbore 48 for enhancing the flow of ambient air into the element to be heated before being inhaled by the wearer. In the preferred embodiment, there are a pair of throughbores 48 laterally spaced from each other, in a generally central region of the element 32. In a still further preferred embodiment, two ½″ diameter throughbores 48 are placed ½ way between to the upper heating element edge 44 and the bottom heating element edge 46 and are separated by 1.5 to 2″ along the length of the element 32. The throughbores 48 enhance air flow through the mask 40.

Still another feature of the face mask 40 is that the heating element 32 is dimensioned to block less of the area of the mask, and having a dimension of 3.5 inches long along length “L” and 2 inches wide along width “W”. In another contemplated element 32, the length “L” is 5 inches and the width “W” is 3⅞ inches. In another contemplated element 32, the length “L” is 3½ inches and the width “W” is 2 inches. In still another embodiment, the length “L” is 3¼ inches and the width “W” is 2¾ inches.

In the preferred embodiment, as seen in FIG. 4, the disposable face mask 40 is 6¾″ in length. From the top edge 28 to the bottom edge 26 it is 3¾″. The mask 40 is pleated so that it can expand from top to bottom in order to wrap around one's face, from the bridge of the nose to under the chin. The expanded dimension is 5½″ from the top 28 to the bottom edge 26.

The battery powered heating element 32 preferably occupies sufficient enough area to provide heating, while not blocking a significant amount of air from flowing through the mask. The heating element 32 currently being worked on has the following dimensions.

As seen in FIG. 4, the heating element 32 is optionally powered by a battery 50 connected to the element via a conventional power cord 52. It is contemplated that the battery 50 is worn on the wearer's person in a pocket or the like. Also, the battery 50 is contemplated as an 11.1 V, 2600 mAh 3-Level Remote Controlled Li-ion battery, or a 7.4 V Li-ion battery, any of the above preferably with a key Fob®, depending on the temperatures needed by the wearer, as well as the purpose of the mask. It is envisioned that wearers using the mask 40 for keeping warmer outdoors in colder temperatures would prefer temperatures within the mask to be approximately 120-130° F. Such temperatures are considered to be very comfortable against the skin. Relatively higher temperatures for use in colder environments are contemplated as being in the range of 180-200° F. The latter range would result in the inhaled air being the average of one's exhale and one's inhale (140-150° F.) and potentially act to logarithmically reduce the viable virus inhaled. The power cord 52 exits a side 54 comes out the side of the element 32 and subsequently the side of the mask 40. The power cord 52 optionally exits the bottom edge 26 of the mask as an alternative. In one embodiment, the heating element 32 is wired with Bus Bars 55 which are imbedded wires designed for the electricity to flow through a FabRoc™ conductive media, and are separated by 2 inches. The actual FabRoc™ conductive media pad is 4″ long by 2 and 5/16″ wide. Other sizes of the heating elements are contemplated and various distances between the Bus Bars are contemplated to result in the desired temperature profile.

In addition, the final temperature of the inhaled air is actually the average of one's exhale (98.6° F.), and the temperature of the heating pad or air-activated warmer. It is envisioned to use either of these heating modalities in a non-disposable (reusable) face mask as well.

The heating element 32 is preferably covered in a washable and disinfectable material, in order for it to be cleaned and reused. There may not be need for perforations, to allow for additional airflow through the mask if, as seen in FIGS. 5 and 7, the heating element 32 occupies approximately 25-60% of the total open mask surface area, which refers to the mask laid upon a substrate and expanded so that folds or pleats are stretched out. It is contemplated that the amount of surface area of the face mask occupied by the heating element 32 varies from 25-60% of the total open mask surface area.

If an air-activated warmer is used for heating the dimensions of the larger air-activated warmers are 5″ long by 3 and ⅞″ wide and can be too large to allow for the passage of air easily through the mask. It is contemplated that the size of the heating element can vary in order to result in the desired temperatures along with providing for enough unoccupied space to allow for airflow through the mask. As a result of this, additional sizes may be suitable using an appropriately matched power source i.e. battery. In this regard, either 7.4V, 2600 mAh or a 11.1V, 2600, mAh batteries are examples. As a result of this, a normal size air-activated warmer (hand warmer) 3.5″ long by 2″ wide would suffice and function best.

Referring now to FIG. 6, the present mask 10 is shown with the temperature control element 32 being a non-disposable reusable cooling pack as mask 10 a, and the mask 10 b, which is a non-disposable washable fabric mask with the same non-disposable and reusable cooling pack shown hidden within the pocket 30. As shown in FIG. 6, the cooling pack 32 has dimension of 4.75×3.25 inches. In this embodiment, the temperature control element (cooling pack) 32 takes up approximately 80% of the surface area of the mask 10.

Referring now to FIG. 7, the present face mask 10 is shown with a reduced size temperature control element 32 located in the pocket 30.

Referring now to FIG. 8, an alternate embodiment of the present face mask is designated 60. Components shared with the masks 10 and 40 are designated with identical reference numbers. The main distinction of the face mask 60 is that it is of the “duckbill” type known in the art. This mask 60 is not contemplated as being equipped with the pocket 30 for receiving the temperature control element 32 as described above. Instead, the heating element 32 is up against the inner surface of inside of the mask, held in place by horizontal parallel, and vertically spaced ¼″ wide fabric cords 42.

Referring now to FIG. 9, an alternative embodiment of the present face mask is designated 70. Components shared with 10, 40, and 60 are designated with identical reference numbers. The main distinction of face mask 70 is that it is not disposable and able to be laundered. A supplemental double layer of polyester mesh 71 is sewn to the bottom and side edges of the inside of the mask and the top edge has an opening 30 for the placement of a heating or cooling element. An additional small ¼″ opening 54 is present on the left side for passage of the power cord if this is the chosen heating modality.

While a particular embodiment of the present medical heated face mask has been described herein, it will be appreciated by those skilled in the art that changes and modifications may be made thereto without departing from the invention in its broader aspects and as set forth in the following claims. 

1. A heated medical face mask, comprising: a first outer layer having an outer surface and an inner surface; a second, inner layer having an outer surface and in inner surface; said first and second layers being fastened together around corresponding peripheral side and bottom edges but being open along an upper edge to form a pocket; and a temperature control element being releasably located in said pocket.
 2. The medical face mask of claim 1, wherein said temperature control element is one of a heating element and a cooling element.
 3. The medical face mask of claim 1, further including at least one fastening loop secured to each said peripheral side edge.
 4. The medical face mask of claim 1, further including an elastic strap having a pair of free ends, each said end being secured to a corresponding said side edge of said joined first and second layers.
 5. The medical face mask of claim 1, further including a material or textile tie, each having a free end, each said end being secured to a corresponding said side edge of said joined first and second layers at a corner or at the edge adjacent to the corner.
 6. The medical face mask of claim 2, wherein said heating element is one of air-activated, battery powered and rechargeable.
 7. The medical face mask of claim 1, wherein said temperature element has an area dimensioned to be approximately 80% of an area of said joined first and second layers.
 8. The medical face mask of claim 1, wherein said temperature element has an area dimension to be approximately 25% to 60% of an area of said joined first and second layers.
 9. The medical face mask of claim 1, wherein said pocket is defined by a supplemental layer of material dimensioned for at least partially wrapping around said temperature control element, as a continuation of the second or inner layer.
 10. The medical face mask of claim 1, wherein said temperature control element is dimensioned to block approximately at most 80% of an area of said outer layer.
 11. The medical face mask of claim 1, wherein said temperature control element is provided with at least one throughbore.
 12. The medical face mask of claim 11, wherein said temperature control element has a pair of said at least one throughbores laterally spaced from each other.
 13. The medical face mask of claim 1, wherein said temperature control element is dimensioned to be 3.5 inches long by 2 inches wide.
 14. The medical face mask of claim 1, wherein said temperature control element is dimensioned to be 5 inches long by 3⅞ inches wide.
 15. The medical face mask of claim 1, wherein said temperature control element has a surface area that is 40-60% of a surface area of the mask. 